Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

This study has been completed.

Sponsor:

SCRI Development Innovations, LLC

ClinicalTrials.gov Identifier:

NCT00193505

First Posted: September 19, 2005

Last Update Posted: May 3, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:

complete response rate

Secondary Outcome Measures:

progression-free survival

overall survival

Estimated Enrollment:

40

Study Start Date:

October 2003

Study Completion Date:

August 2005

Primary Completion Date:

August 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Upon determination of eligibility, patients will receive:

Ifosfamide + Carboplatin + Etoposide + Rituximab

Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma

Persistent lymphoma after one or two previous chemotherapy regimens

Patients should not be considered candidates for high-dose chemotherapy

Ability to perform activities of daily living with assistance

Measurable or evaluable disease

Age > 18 years

Adequate bone marrow, liver and kidney function

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193505